A Double-Blind, Randomized, Crossover Evaluation of the Pharmacokinetics of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R); and an Open-Label Safety and Efficacy Evaluation of rFIX-R in Previously Treated Patients With Moderate to Severe (FIX:C≤2%) Hemophilia B

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Study Completion Date:

September 2005

Eligibility

Ages Eligible for Study:

12 Years and older (Child, Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Moderate to severe hemophilia B (FIX: C ≤2%)

Previously treated patients (PTPs) with ≥150 documented exposure days

Age ≥ 12 years (US sites only)

Exclusion Criteria:

Detectable factor IX inhibitor defined as ≥0.6 Bethesda Units for pooled plasma reported by the local laboratory (family history of inhibitors will not exclude the patient)

Patient history of factor IX inhibitor replacement therapy

Patient unable to be off factor IX replacement therapy for at least 5 days without bleeding

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093210